CTI BioPharma Corp.
Q3 2015 Earnings Call Transcript

Published: 6 Nov 2015

[Operator:]

Good day and welcome to the CTI BioPharma Third Quarter 2015 Financial Results Conference Call. Today’s conference is being record. At this time, I would like to turn the conference over to Monique Greer. Please go ahead, ma’am.

[Monique Greer:]

Thanks, Kevin, and welcome everyone to our third quarter 2015 financial results conference call. The press release reporting our financial results can be found on the homepage and in the Investors Section of our corporate website at ctibiopharma.com. Following the formal remarks by management today, the conference call will be opened for questions. Joining me today are Jim Bianco, President and Chief Executive Officer; Matt Plunkett, Executive Vice President of Corporate Development; Bruce Seeley, Chief Commercial Officer; Lou Bianco, Executive Vice President of Finance; and Jack Singer, our Chief Scientific Officer. Before we begin, please note that during course the call, we will be making forward-looking statements based on current expectations. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by forward-looking statements. Additional information concerning these risks and uncertainties is contained in the press release reporting our financial results for the third quarter 2015 in the Risk Factors section of the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, and in the Company’s other periodic reports and filings with the Securities and Exchange Commission. I will now turn the call over to Jim.

[Jim Bianco:]

Thanks, M. Good afternoon everyone. I’m going to start by giving you an update on some of the achievements and upcoming milestones. As you know, we’ve recently announced a plan to submit a new drug application to the U.S. FDA following a really productive pre-NDA meeting for pacritinib in the second quarter. We expect to begin it as a rolling submission this month and we’ll complete the submission of the NDA before year-end. We plan on requesting both accelerated approval and priority review for the treatment of patients with intermediate and high-risk myelofibrosis, who have low platelet counts of less than 50,000. Accelerated approval is being for indications where there remains an unmet medical need and as the FDA noted to us currently there are no approved drugs for patients with myelofibrosis, who have platelet counts below 50,000. Now submission of an NDA after a single Phase 3 trial under accelerated approval if were granted priority review designation could potentially reduce the time to market by up to 14 months but rather than I’m waiting for the results from the PERSIST-2 trial to be available. Now the NDA is going to be based primarily on the data from PERSIST-1 Phase 3 study, as well as some guidance that would be received from the FDA, which was pulling data from the Phase 1, 2, and 3 studies in a separate study report specifically for the patient population with low platelets of less than 50,000 per microliter. As you may remember data from the PERSIST-1 towards our first randomized Phase 3 study for pacritinib from patients with myelofibrosis including those that had disease-related anemia and thrombocytopenia was presented at the oral presentation at the 51st meeting at ASCO earlier this year. And as you know results, when compared to best available therapy exclusive of a JAK2 inhibitor, pacritinib resulted in a significantly higher proportion of patients achieving the primary endpoint of 35% or greater reduction in spleen volume. And those benefits were also observed among patients with very low-level of blood platelets as you know condition that’s called severe or life-threatening thrombocytopenia. If you’re not familiar with thrombocytopenia, normal platelet counts ranged from 150,000 to 400,000. In our PERSIST-1 study, 32% of the patients had platelet counts below 100,000 and half of those 60% had platelet counts less than 50,000. At study entry, I’ll give you an example of the sickness of the patient population, 46% of our patients with thrombocytopenic. Now in addition to disease-related thrombocytopenia, approximately 40% of the patients at study entry also had disease-related anemia, i.e., of hemoglobin below 10. And if you look at some of the data from the Mayo Clinic in their experience in 1,000 patients, they showed that at diagnosis only about 18% of patients are thrombocytopenic, but over time, 31% will develop disease-related thrombocytopenia one year after diagnosis. And while 38% are anemic at diagnosis that raises to 64% of patients one year after diagnosis will be anemic and 45% of the them will require a blood transfusion based upon their disease. So given the high percentage of patients, who developed disease-related cytopenias, JAK2 therapies that are myelosuppressive, while effective in spleen and symptom control, so the majority will require dose reductions in more than half of patient and offering that doses that are minimally effective in symptom control. Based on market research, there’s clearly a significant unmet medical need for a non-myelosuppressive JAK2 inhibitor for really the majority of the patients with disease related cytopenias and myelofibrosis. So our pursuit of accelerated approval pathway for pack in MF and disease-related thrombocytopenia really represents just the first leg of our regulatory and commercial strategy for this non-myelosuppressive unique JAK2 inhibitor. Unlike other JAK1/2 inhibitors, the kinome spectrum of pack is unique and that it lends itself to a distinctly different biological profile based on the innovation of two very important targets

[Bruce Seeley:]

Thanks, Jim. Good afternoon everybody. As Jim mentioned, we have been working hard together with our partner Baxalta on preparations for the successful launch of pacritinib. Over the past nine months, the commercial team has been focused on thoroughly understating the myelofibrosis market landscape, and preparing the commercial organization for launch. We’ve conducted market research with MF patients to understand more about their disease and what’s important to them in terms of their unmet needs. We’re also engaged in access and reimbursement research and have conducted several Scientific Advisory Boards with leading academic and community healthcare providers. In order to gain their insight as to best position pacritinib to address the needs of patients, caregivers, and physicians. During these advisory boards, we share the product profile of pacritinib and ask the participants a series of questions. And what we’ve heard loud and clear is that physicians are seeking a new treatment option for their patients particularly for those patients with less than 50,000 platelet counts, a pollution without an approved and effective treatment. Unlike other myeloproliferative neoplasms, namely PV and ET, myelofibrosis is one of the most aggressive of the MPNs with debilitating symptoms that dramatically reduce patients’ quality of life, with survival from diagnosis still well under a decade. MF has a prevalence of about 18,000 patients in the U.S. and unlike many other blood cancers, myelofibrosis is as difficult to treat chronic disease and like their patients, physicians struggle to find effective treatments and are always looking for new options, particularly for those patients with low platelets, who struggle with cytopenias namely thrombocytopenia and anemia as a result of their disease. Within one year following diagnosis, 58% of patients develop anemia with 28% presenting with thrombocytopenia. And these percentages grow to 64% and 31% more than a year from diagnosis. The extent to which MF patients develop disease related cytopenias is greater than what was previously recognized and underscores the need for a non-myelosuppressive JAK2 inhibitor to maximize efficacy without having to compromise the benefit at the extends of side effects of the therapy. We and our partner Baxalta believe that the myelofibrosis market is estimated to approach approximately $2 billion by 2020, which represents significant potential. With up to 70% of patients having to discontinue their current therapy or reduce their dose because of treatment related anemia or thrombocytopenia, pacritinib may provide flexibility in simplifying the management of myelofibrosis for all patients regardless of platelet counts. In addition, the lack of myelosuppression makes pacritinib an attractive candidate for investigation in combination therapy as new targeted agency emerged in the search for curative approach to this disease. Now, we’re showing more about our plans to address the unmet need of patients with myelofibrosis in the coming months. Now, I’d like to move on to our current commercial product PIXUVRI. Based on the efficacy and safety profile and the clear unmet medical need in aggressive B-cell lymphoma, in 2012, the European Commission granted conditional marketing approval for PIXUVRI. And as we’ve previously described, in connection with the approval, we’re conducting the PIX306 post authorization trial, which compares PIXUVRI and rituximab with gemcitabine and rituximab in the setting of aggressive B-cell. PIX306 is intended to support the conversion of our EU conditional marketing authorization to a full approval to extend the PIXUVRI development program into second-line aggressive NHL, which represents an earlier line of treatment, and to include combination therapy with rituximab on the product label. If positive, the results from the PIX306 study may form the basis for a possible submission to FDA in the U.S. And we expect to complete enrollment for this event driven trial in 2016. As we reported today, net product sales of PIX for the third quarter and the nine months ending September 30 were $0.7 million and $2.4 million respectively, compared to $2 million and $4.4 million for the same periods in 2014. Part of this discrepancy and net sales to year-over-year, relates to the decline in the average exchange rate for the euro for our euro denominated sales as well as pricing and volume variances between the periods presented. In addition, one of our challenges to date has been introducing a monotherapy treatment in Europe where combination therapy is readily used when treating cancer patients. And we believe that generating data from PIX306 in a combination regimen with rituximab will help us to move up to treating patients in second-line and beyond. And a number of hematologists in Europe have been generating interesting data for PIXUVRI in exploratory investigator-sponsored trials for the treatment of aggressive NHL and we do expect to see additional publication of these data in the future. And the interest will continue in the exploration of PIXUVRI and such investigator agency in a trial. With that, I’ll turn the call over to Matt, who will review our financials for the quarter and the proceeding nine months.

[Matt Plunkett:]

Thank you, Bruce. I will now briefly review our financials for the third quarter and year-to-date as well as provide an update for the remainder of 2015. Please refer to our third quarter 2015 press release issued earlier today for complete details. For the three months ended September 30, 2015, we reported a net loss of $32.6 million or $0.19 per share, compared to a net income of $4.6 million or $0.03 per share for the same period in 2014. Net loss for the first nine months of 2015 was $93.8 million or $0.54 per share, compared to a net loss of $51.8 million or $0.36 per share for the same period in 2014. Total revenues for the third quarter and the nine months ended September 30, 2015 were $1 million and $4.8 million, respectively, compared to $39.5 million and $42.3 million for the same periods in 2014. The decrease in total revenue is primarily due to recognition of milestone payments in 2014, specifically a $20 million development milestone payment received from Baxalta for completion of enrollments in the PERSIST-1 Phase 3 clinical trial of pacritinib and $17.3 million from an upfront payment under the PIXUVRI collaboration agreement with Servier. Turning to our balance sheet, we ended the third quarter with cash and cash equivalents totaling $46.4 million. We’ve recently strengthened our balance sheet with an underwritten public offering of stock representing – resulting in net proceeds of approximately $46.5 million, which is not included in our Q3 cash position. Proceed from this rates will be used primarily for support of the pacritinib commercial launch in the U.S. and for conducting additional studies of pacritinib and indications outside of myelofibrosis. As stated in our Q3 financial results press release today, we continue to expect our non-GAAP operating loss for 2015 will be approximately $75 million to $85 million. We are updating our prior net revenue financial guidance and now expect total revenues for 2015 will be approximately $30 million to $45 million, which are primarily based upon current expectations regarding net product sale for PIXUVRI, commercial operations and license and contract revenues under the agreements with Baxalta and Teva. With that, I’ll now turn the call back to Jim.

[Jim Bianco:]

Thanks, Matt. Clearly an exciting time for CTI BioPharma. We’re committed to working with the agency bring equipment of patients with [indiscernible] as possible. You may have noticed we’ve also been making a number of changes both in seniors management and the Board of Directors really an effort to optimize the leadership and governance to make CTI the successful company, it’s really shaping up to become. As always, we want to thank our employees for their commitments, commitments and tireless efforts and when I say tireless, I’ll underscore tireless as everyone’s in the NDA mood. Now as we look ahead to the remainder of the year and into 2016, let me just summarize a couple of key takeaways from today’s update. So we’re on track for beginning a well in submission this month with the completion of the submission before year end. We’re focused on completing enrollment on the second Phase 3 trial PERSIST-2 and as I mentioned, we believe this trial can serve as a post-approval confirmatory trial. If PAC is approved on re-accelerated approval on the initial NDA, we also believe that patient population in PERSIST-2 serves to expand the label indication for pacritinib as well. We’re supporting Baxalta in the submission of their European regulatory application for PAC, which is based on the PERSIST-1 data and we’re advancing pacritinib development in a number of other hematologic malignancies again in collaboration with Baxalta. We’re continuing to drive towards completing enrollment of PIX306. And then lastly, to see the staff, is to clear the winner in the randomized L-1 AML trail. We would explore and define a password registration in 2016 based on those data. Additionally, we plan to report on several ongoing clinical trials involving pacritinib [ph] to see the credit in the upcoming ASCO meetings, as well as other scientific meetings in the upcoming months. With improved balance sheet, strong last-stage pipeline near-term, potential launch of pacritinib and a team of dedicated employees focused on delivering new cancer therapies for patients. We believe we’ve established a strong foundation for continued progress and look forward to providing future updates. So this will conclude the formal presentation, and we’ll have the operator now open the call for questions.

[Operator:]

Thank you. [Operator Instructions] And we’ll take our first question from Charles Duncan (Piper Jaffray). Your line is now open.

[Charles Duncan:]

Hi guys, thanks for taking the question. And congratulations on the progress in quarter. First of all I wanted to ask you a little bit about some of the very, it sounds like very deep dive work you’ve been doing on transfusion independent and anemia in myelofibrosis. Can you provide a perspective at this time in terms of the impact on the potential market opportunity, especially with regard to considering the pharmacoeconomic value of the drove in that really talking about pricing, but just a sense of how you see that shaping up?

[Jack Singer:]

Good point, Charles, I mean we have seen and continue to observe that hemoglobin levels significantly increase over time compared to the BAT arm. And amongst patients who are severely thrombocytopenic their counts these are transfusion independent patients. So here is, in other words, there’s another transfusion background to deal with. So it’s a true increase in baseline hemoglobin, and in platelet counts and as we mentioned, the transfusion independence continues to be observed even during the follow-up period. And so when you look at the fact that 64% of patients are going to be anemic and that if you have hemoglobin below 10, this was a statistics that was shocking when I heard it at the first ASCO Expert Panel of advisory board that we did. I think Dr. Odenike [ph] said well, I have a head [ph] patient with a hemoglobin of 9.5. And I give him the recommended dose of ruxolitinib, that patient will drop their hemoglobin within four to eight weeks by 35% taking it below seven making him a transfusion candidate. And transfusions are not benign in this elderly patient population. And so if I have patient who has anemia of which more than half of my patients do, why would I put him on the drug, that’s going to make them anemic and require transfusions within one to two months of starting therapy. And then I have the dose reduced and I lose the efficacy component to it to try to manage side effect. So I think in the context of what the market is really looking for, ruxolitinib is a good drug, but it is the only drug. And I think when you come in with the version of the drug that doesn’t have the primary side effect that the disease has, that will be welcomed be the treatment community as really, I think I heard it at ASCO that this could practice changing, because right now they have the dose intensity with ruxolitinib is poor. People are giving up on maximizing the efficacy to moderate side effect profile and it’s become complacent with that and the physicians if you ask, they’re okay with that, because they don’t have another choice. And so if you can maximize efficacy, we have a dose intensity of almost 99%, versus less than 70%, in the COMFORT trials. I don’t know what it is in the real community. If you’re doing five milligrams and ten milligrams in half the patients, then your dose intensity is in the 20% to 25% range, compared to the recommended dose of 40 milligrams a day. And so we think that the market opportunity is much favorable than the initial indication. And we think that PERSIST-2 study will actually address a number of these questions head-on against ruxolitinib and really provide head-to-head comparison that were superior to low doses of ruxolitinib. And we work in patients who had prior ruxolitinib, which are really the majority of the patients that we’re seeing, coming into the patients screened for PERSIST-2.

[Charles Duncan:]

I appreciate that color and thank you for bringing up PERSIST-2. I know it’s all about PERSIST-1 in the near term, but are you confident that in your kind of keeping an eye on how things are going in PERSIST-2, be confident that clinicians are using if they’re using ruxolitinib, they’re using it to the label, dosing to the label in that trail?

[Jack Singer:]

Yes, so we provided a little color around this in the past. If you look at the patients that come into the study, based on PERSIST-1 we anticipated that half the patients would not be eligible for rux either below 50,000 and half the patients on this study I think 49% coming with platelet counts below 50,000 and typically not on ruxolitinib. The other half are between 50,000 and 100,000 in those patients for the most part about 60%, 65% of them are either on rux – or had prior ruxolitinib. And the dosing at there on rux are predominantly 5 milligrams and 10 milligrams per day. And when they get randomized after the rush out period if they get randomized the BAT, the majority of them go back on rux at 5 milligrams or 10 milligrams a day. That is – characteristics of the treatment pattern in the United States. In the United States physicians start with 5 milligrams and 10 milligrams a day and most did not titrate. And in fact that’s what we’re seeing makes them 5 milligrams and 10 milligrams a day. And so we know from the FDA zone briefing document on the pharmacodynamic data, the PK/PD data that when you get the doses below 20 milligrams a day, no patient in the comfort study hit either the TSS or the spleen volume reduction end point. So at 5 milligrams and 10 milligrams per day, the JAK that signaling inhibition is almost gone. It’s like 20% versus 90% at the recommended dose two hours versus eight hours at the recommended dose. And so you are clearly sub-therapeutic and will be believe is that if we’re superior to the current treatment practices in the United States of 5 milligrams and 10 milligrams a day of ruxolitinib that physician will obviously connect those docs that they are giving sub-therapeutic doses of the drug when they can give full therapeutic doses of the drug without getting into trouble with regards to myelosuppression.

[Charles Duncan:]

Okay. And last question is regarding the upcoming ASH Meeting we’re getting our arms around that. It has been a busy day, but I wondered if when you look through the ASH tracks, if there were any one or two things that stood out for you in terms of things that you would be looking forward to seeing additional details on April meeting.

[Jim Bianco:]

Well, I think the subset analysis from the niche which is an oral presentation is very interesting and especially just knowing the rest of the data. I think the validation of IRAK1 in AML as well as in CML is very intriguing. Remember you CSF1 is an important target and IRAK1 we mentioned as for last year and a half, it’s becoming increasingly more important than hematologic malignancies. And then tosedostat I mean clearly if we win in the pick a winner study, I think that would be a very nice complement too in oral presentation for Dr. Bassani in his group. So we’re really excited. We think this is going to be a real eye opener in terms of what both biology and the translation of medicine potential for the drugs are.

[Charles Duncan:]

DNA test here in 2016. I appreciate added color.

[Jim Bianco:]

Thanks, Charles.

[Operator:]

Our next question comes from Bert Hazlett [BMO Capital Markets]. Your line is now open.

[Bert Hazlett:]

Thanks. My congrats on the progress to, it’s has been pretty remarkable year for your folks for pacritinib. My question is based on the additional data that has been done with thrombocytopenia and anemia. I think I’ve asked this before of you Jim and the crew. You’ve done some additional work and I appreciated as well. But are those the same patients, the patients that are anemic and the patients just thrombocytopenic and if they are could you just describe the overlap at maybe initially and then maybe at one year to the best that you know what.

[Jim Bianco:]

So for sub 50,000 platelet group, that’s platelet population where we show the significant increase in platelet counts over time, not transfusion related, i.e. this was truly from baseline increasing their accounts overtime. We can tell you that, that continues in the second follow-up period. And some of those patients were anemic and transfusion dependent and became transfusion independent. Not all of them. Again, we’re talking about small numbers and frequency overall I think 15%, we’re transfusion dependent based on the real criteria. And that’s a very stringent criteria. Some people just look at having red cell transfusion in the last 30 days as quote-unquote being anemic and meaning transfusion dependent excuse me. So I don’t know, if that answered your question Bert, but the answer is even in the higher risk sub patient population, it was the mix of those patients who both became transfusion independent and have their platelet counts increased over time.

[Bert Hazlett:]

Okay. I guess, I’m also just trying to get a better sense of what the opportunity might be as we think about the anemic patient. We – I think we’ve been – but we’ve had a pretty good shot at characterizing this thrombocytopenic group. But I’m just trying to layer on those that are anemic as well. Those that might be consider for pack. In addition to those that are thrombocytopenic dose with very low platelet.

[Jim Bianco:]

Right. So what we knows that patients who have hemoglobins below 10 versus patients will have hemoglobins above 10, don’t change over time on pack, unfold those pack at a year, longer than a year. And so unlike rux where you initially, immediately get this fall in hemoglobin requiring transfusions and/or dose titration i.e. reduction. We don’t see that. And so from a practice standpoint why would you put somebody who’s anemic on a drug that’s going to make them more anemic. I mean, that’s clearly a message. The other message here is that increase in the hemoglobin I mean everyone was all excited about the YMI product. Well, the blooms going off that rows I mean we had a significant increase in baseline hemoglobin over time. And so we do think that we are seeing narrow modification – modifying activity, I mean JAK and whether it’s CSF1 or IRAK or a combination of both, it’s clearly that you’re doing you’re behaving different than just JAK2 inhibition story by itself.

[Jack Singer:]

I just want to make, this is Jack Singer, I just wanted to make a couple of comments on the anemia. First that burden on patients is huge. Dealing with elderly patients, the transfusion requirement means that they are getting a couple of units of blood which can take six to eight hours and in clinic, it takes a fair amount of position and nurse time as well. And I would have to guess that each unit cost several thousand dollars all in cost. The other issue is that anemia by itself is prognostic. Patients with hemoglobin below 10 more transfusion requirements have a much shorter survival. And we don’t know – we know that’s true de novo disease we don’t know if it’s in the acquired transfusion requirement that’s also true, but I would – I don’t think anybody would be surprised if that were the case. So this is really a major issue for patients and physicians. Patients can’t tell whether they’ve thrombocytopenic, but they feel very poorly when they are anemic. They have less energy. They can’t do things and requires medical intervention. So I think this is a big issue, it’s at least half of the patients that is most of the patients that physicians have to spend time with. So I think this is – we’ve heard [indiscernible] continuously that this is the major issue in treating patients with myelofibrosis. And having a drug which actually, not only doesn’t make it worse, but actually makes it better, would be unique.

[Bert Hazlett:]

That’s helpful. And I guess just a little bit more about may be specific labeling and the specific of NDA filing, you’re going to be focused on those with very low platelet counts of below 50,000. How will the anemia discussion that we’re – you’re referring to – be referred to in the label. Does it need to be referred to in the label or can the clinic trial results that you’ve published and described drive the interest in pacritinib just based on what’s already out there.

[Jim Bianco:]

So it would be highly and probable it would be a label aspect again, because these are secondary end points. That you are looking at, not a primary endpoint of a study. And so the FDA not likely included in your label, but clearly from a biology mechanism of action and differentiation in the literature. I can tell you just and Bruce, you’ve been add tons of ad boards. It’s very clear that they pick this up and immediately recognize it. You are not myelosuppressive and you can do things in their patient population at doses that they can’t away with drugs.

[Bruce Seeley:]

Yes. I would agree. I would just add that to sort of highlights Jim’s earlier comment about when you are in an ad boarding represent the target profile for pacritinib. The physicians connected dots on their own. And it’s amazing to be able to watch on, look at the data, look at the cytopenia profile of pacritinib and they get it. They get it right away. And that’s very encouraging for us as we got forward in the marketplace from a differentiation in a competition perspective.

[Jim Bianco:]

Just one comment on the label, although this might get into an efficacy claim, it would be included in the safety portion of the drug, because you would see that grade 3/4 anemia was not a consequence of the drug as, so it was still the first one.

[Bruce Seeley:]

Yes, absolutely, yes.

[Bert Hazlett:]

Okay, terrific. And just two more quick ones. Maybe you’d mentioned it previously and if I miss that I’m sorry, would you plan to present more mature data for from PERSIST-1 i.e. 48-week data at ASH. I don’t know whether you have an ability to describe that. And secondly, Charles [indiscernible] directly, but I’m. Have you an any more direct thoughts on pricing given the pricing of other JAK competitors out there.

[Jim Bianco:]

With regards to 48-week data, I’m going to pumped on that and turn it over to Bruce and talk about pricing.

[Bruce Seeley:]

So we’ve had – we are already working on pricing research along with our partner Baxalta. And as you know, there is a lot of things that go into decision on pricing and we’re not making a pricing decision. Now our research is continuing, but we’re looking at things such as benchmarking and the industry. So that it makes at a little bit easier for us we’re not first in class. There is a benchmark in the marketplace right now. We’re also following very closely, the research that we’re doing with payers, with patience and we’re asking questions about benchmark pricing and the tradeoff in the marketplace there. And I would say that ultimately, what I would say – well, so we have not made a final decision on pricing nor really make a final decision on pricing until much closer to the launch of the product. But the way I would describe it is that given the profile pacritinib in the marketplace particularly in those patients that are most hard to treat. It gives us some good flexibility from a pricing perspective for a pacritinib.

[Bert Hazlett:]

Thank you for the additional color and congratulations again on the progress.

[Jim Bianco:]

Thank you.

[Bruce Seeley:]

Great.

[Operator:]

We will take our next question from Bob Ai [Wallachbeth Capital LLC]. Your line is now open.

[Bob Ai:]

Hi, thank you for taking my question. Can you hear me well?

[Jim Bianco:]

Yes, we can hear you Bob.

[Bob Ai:]

Hi Jim, in your communication with FDA regarding the NDA signing based on the PERSIST-1 result? Did any of the – do you have any communication writing or just a oral communications?

[Jim Bianco:]

No, of course we have a correspondence both in writing from the initial answers to our questions and then when we had a meeting with them in person, obviously, the minutes they come out from that meeting just confirm kind of the plan in the strategy going forward. They were – I’d say one thing they were very helpful, provided some very specific guidance about what they wanted to see, what we need to do. This was not like it will be a review issue. This is the population that qualifies to what you are looking for, here is what we want.

[Bob Ai:]

And also I’ve question about the PERSIST-2. Are you going to presenting the depression profile just without a come out or really don’t – you are trying to do that.

[Jim Bianco:]

Patient profiles, I mean we’re obviously blinded to group demographics, but nothing specific now.

[Bob Ai:]

Okay. No, I mean like in generally, just the whole group not – of course [indiscernible]?

[Jim Bianco:]

I mean, the whole group looks like the – like the 42% of the PERSIST-1 study below a 100,000 with the exception of JAK2 therapy right, otherwise the demographics are going to comparable, which is again why we said PERSIST-2 is really be risk study.

[Bob Ai:]

Wondering like how many patients that will end up taking jakafi?

[Jim Bianco:]

Yes. I said that early Bob.

[Bob Ai:]

I’m sorry. I missed that maybe.

[Jim Bianco:]

Have the patients don’t qualify because they below the 100 – below 50,000 for the 50% that have above 50,000 between 50 and 100 approximately 60% of those patients, if they get on the BAT, we will get back on to drugs, typically it dose as a 5 milligrams or 10 milligrams per day.

[Bob Ai:]

Okay. Thank you. Sorry, today is the lot of conference call is going on.

[Jim Bianco:]

Yes, [indiscernible]

[Bob Ai:]

Thank you. And it appears we have no further questions at this time. I’ll turn the call back to Dr. Bianco for closing comments.

[Jim Bianco:]

All right. Thank you. Thanks everyone for joining us on the call. We appreciate your support. Look forward to seeing many of you at the upcoming investor conferences, scientific meeting and our Analyst Day on Sunday at ASH at 11 AM. So a lot of exciting stuffs waiting, thanks

[Operator:]

This does conclude today’s teleconference. You may now disconnect. Thank you and have a great day.